Trial Information

Multicenter Trial of CPE for Maxillofacial Prosthetics

Maxillofacial prosthetics is a subspecialty of prosthodontics, providing the clinical
rehabilitation treatment of patients who have lost parts of the face due to cancer, trauma,
or birth defects. It is an orphan field that:

- treats few patients, making the subspecialty unprofitable for manufacturers to develop
new materials;

- offers fundamental rehabilitation and improvement in the quality of life to patients
who may have exhausted personal or third party funding; and

- provides a dental solution to an essentially medical problem.

Silicone rubber materials have been used for facial rehabilitation for more than 4 decades
with few improvements. There is a clear need for new, alternative, and more economic
materials for extraoral maxillofacial prostheses. Research at Gulf South Research Institute
in New Orleans by the Principal Investigator and others in the 1970s and 1980s developed an
alternative low-cost thermoplastic industrial rubber material (chlorinated polyethylene,
CPE) that met all toxicological (safety) and physical (effectiveness) requirements. A Phase
2 clinical trial at the time yielded equivocal results when compared to conventional but
costly silicone rubber products.

This research is a controlled, randomized, single-crossover, double-blinded
investigator-initiated multicenter Phase 3 clinical trial treating 100 patients that
evaluates:

- experimental thermoplastic CPE; and

- control silicone (Silastic Adhesive A/MDX4-4210) materials for non-inferiority of CPE
based on functional and subjective characteristics, and on the quality of life.

The clinical centers of the trial are at M.D. Anderson Cancer Center in Houston, Texas, and
at the Toronto Sunnybrook Regional Cancer Centre in Toronto, Canada.